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Proteasome Inhibitor
Selinexor Combination Therapy for Multiple Myeloma
Phase 2
Recruiting
Led By Noa Biran, MD
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG 2 or less
Age ≥18 years at time of informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights
Study Summary
This trial is studying the response rate of patients with multiple myeloma who are receiving selinexor in combination with carfilzomib, daratumumab, or pomalidomide.
Who is the study for?
Adults with Multiple Myeloma showing disease progression on current treatments including carfilzomib, pomalidomide, or daratumumab can join. They must have good organ function and be able to follow the study's procedures. Pregnant women, those with serious health issues that could affect participation, recent recipients of certain therapies, or individuals with active infections cannot participate.Check my eligibility
What is being tested?
The trial is testing Selinexor in combination with either Carfilzomib, Daratumumab or Pomalidomide in patients whose Multiple Myeloma has worsened despite treatment. It aims to see how well patients respond to this mix of drugs until they experience disease progression or unacceptable side effects.See study design
What are the potential side effects?
Selinexor may cause nausea, vomiting, fatigue, loss of appetite and weight loss. Carfilzomib can lead to heart problems and shortness of breath; Daratumumab might result in infusion reactions; Pomalidomide carries a risk for blood clots.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but cannot do heavy physical work.
Select...
I am 18 years old or older.
Select...
My multiple myeloma is worsening despite treatment.
Select...
My current cancer treatment is not working.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR) of patients receiving selinexor with carfilzomib and dexamethasone (Arm 1)
Overall Response Rate (ORR) of patients receiving selinexor with pomalidomide and dexamethasone (Arm 2)
Secondary outcome measures
Incidence of Adverse Events [Safety and Tolerability] using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), v 4.03.
MRD Negativity
Overall Survival (OS)
+2 moreOther outcome measures
Analyses of bacterial translocation markers
Analyses of chemokine markers
Analyses of cytokine markers
+13 moreSide effects data
From 2021 Phase 3 trial • 126 Patients • NCT0302923462%
Anaemia
49%
Upper respiratory tract infection
49%
Platelet count decreased
39%
White blood cell count decreased
38%
Hypertension
35%
Hypokalaemia
30%
Neutrophil count decreased
28%
Lymphocyte count decreased
23%
Pneumonia
21%
Cough
19%
Blood creatinine increased
19%
Insomnia
18%
Pyrexia
17%
Hyperuricaemia
17%
Diarrhoea
16%
Hypoalbuminaemia
16%
Hypocalcaemia
16%
Neutrophil count increased
16%
Blood lactate dehydrogenase increased
15%
Blood uric acid increased
15%
Blood pressure increased
15%
Lung infection
14%
Hyperglycaemia
14%
White blood cell count increased
14%
Blood bilirubin increased
14%
Blood glucose increased
14%
Constipation
12%
Blood urea increased
12%
Neutrophil percentage increased
11%
Alanine aminotransferase increased
11%
Hyponatraemia
11%
Hypercalcaemia
10%
Aspartate aminotransferase increased
10%
Blood potassium decreased
10%
Bronchitis
10%
Neuropathy peripheral
10%
Productive cough
10%
Oedema peripheral
10%
Lymphocyte percentage decreased
9%
Leukocytosis
8%
Blood phosphorus increased
8%
Influenza
8%
Blood albumin decreased
8%
Hypoproteinaemia
7%
Prealbumin decreased
7%
Bilirubin conjugated increased
7%
Peripheral swelling
7%
Nasopharyngitis
7%
Hypophosphataemia
7%
Back pain
7%
Abdominal distension
7%
Vomiting
7%
Cataract
7%
Mean cell volume increased
6%
Gamma-glutamyltransferase increased
6%
Hyperkalaemia
6%
Thrombocytopenia
6%
Vision blurred
6%
Respiratory tract infection
6%
Hepatic function abnormal
6%
Nausea
6%
Hypoglycaemia
3%
Plasma cell myeloma
3%
Acute kidney injury
2%
Bone pain
2%
Cardiac amyloidosis
2%
Localised infection
1%
Pain
1%
Periodontitis
1%
Myelopathy
1%
Device related infection
1%
Dysuria
1%
Pleural effusion
1%
Otitis media
1%
Pancreatitis acute
1%
Spinal compression fracture
1%
Lipoma
1%
Cerebral ischaemia
1%
Deep vein thrombosis
1%
Cardiac failure acute
1%
Soft tissue infection
1%
Nerve compression
1%
Chronic kidney disease
1%
Hypotension
1%
Asthma
1%
Bronchiolitis
1%
Pathological fracture
1%
Myolipoma
1%
Neuralgia
1%
Escherichia sepsis
1%
Interstitial lung disease
1%
Obstructive airways disorder
1%
Organising pneumonia
1%
Supraventricular tachycardia
1%
Disease progression
1%
Infusion site extravasation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carfilzomib With Dexamethasone
Trial Design
3Treatment groups
Experimental Treatment
Group I: Pomalidomide-containing RegimenExperimental Treatment3 Interventions
Pomalidomide 4 mg po daily for 21 days. Dexamethasone 20 mg if ≥ 75 years old and 40 mg if < 75 years old on days 1, 8, 15 and 22.
Selinexor 60 mg on days 1, 8 and 15.
Group II: Exploratory/Daratumumab-containing RegimenExperimental Treatment3 Interventions
Daratumumab on current schedule (16 mg/kg IV days 1, 8, 15 and 22 for cycles 1-2; days 1 and 15 for cycles 3-6; day 1 for cycle 7 and on).
Dexamethasone 20 mg if ≥ 75 years old and 40 mg if < 75 years old on days 1, 8, 15 and 22.
Selinexor 100 mg on days 1, 8, 15 and 22.
Group III: Carfilzomib-containing RegimenExperimental Treatment3 Interventions
Carfilzomib 56 mg/m2 on days 1, 8 and 15. Dexamethasone 20 mg if ≥ 75 years old and 40 mg if < 75 years old on days 1, 8, 15 and 22.
Selinexor 80 mg on days 1, 8 and 15.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
2017
Completed Phase 3
~1440
Pomalidomide
2011
Completed Phase 2
~1020
Daratumumab
2014
Completed Phase 3
~1860
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,148 Total Patients Enrolled
20 Trials studying Multiple Myeloma
1,324 Patients Enrolled for Multiple Myeloma
Karyopharm Therapeutics IncIndustry Sponsor
87 Previous Clinical Trials
7,483 Total Patients Enrolled
22 Trials studying Multiple Myeloma
2,124 Patients Enrolled for Multiple Myeloma
Noa Biran, MDPrincipal InvestigatorHackensack Meridian Health
3 Previous Clinical Trials
67 Total Patients Enrolled
3 Trials studying Multiple Myeloma
67 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not expected to live for more than 3 months.I am using effective birth control methods.I am unable or unwilling to take recommended supportive medications.I do not have an active infection needing IV drugs within the last week.You have had a bad reaction to or cannot take glucocorticoids.My kidney function is good as tested within the last 28 days.I cannot take certain medications needed alongside my cancer treatment.My liver is functioning well, as tested within the last 28 days.I have recently undergone radiation, chemotherapy, or immunotherapy.I do not have an active hepatitis A, B, or C infection.I am experiencing complications from a stem cell transplant.My body surface area is less than 1.4 square meters.Women who could become pregnant need to have a negative pregnancy test before joining the study.I have stomach or intestine problems that affect my eating or medication absorption.Your disease can be measured using specific guidelines.I can take care of myself but cannot do heavy physical work.I am 18 years old or older.My condition is smoldering multiple myeloma.My multiple myeloma is worsening despite treatment.My blood counts are within normal ranges as of last week.My side effects from previous treatments are mild as of the first day of the new treatment cycle.My current cancer treatment is not working.
Research Study Groups:
This trial has the following groups:- Group 1: Carfilzomib-containing Regimen
- Group 2: Pomalidomide-containing Regimen
- Group 3: Exploratory/Daratumumab-containing Regimen
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some of the risks associated with Carfilzomib?
"At Power, we rate the safety of Carfilzomib as a 2. That's because, while there is some evidence that it is safe, Phase 2 trials have not yet demonstrated efficacy."
Answered by AI
What outcome is this experiment designed to produce?
"The primary goal of this 30-month clinical trial is to observe the Overall Response Rate (ORR) in patients who receive selinexor, carfilzomib, and dexamethasone concurrently. Additionally, researchers will be measuring for Progression Free Survival (PFS), Overall Survival (OS), and Time To Next Treatment (TTNT) as secondary objectives."
Answered by AI
Are there any other published papers on Carfilzomib's effects?
"Carfilzomib was first studied 18 years ago at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. So far, 1208 studies have been completed while 688 are still recruiting patients. New jersey's Hackensack has a high concentration of these active trials."
Answered by AI
What disorders has Carfilzomib been shown to improve?
"Carfilzomib is frequently used to treat ophthalmia, but it can also be employed to manage communicable diseases and branch retinal vein occlusion."
Answered by AI
How many individuals are being recruited for this research project?
"Yes, the trial is currently looking for 96 participants across 2 sites, as reflected on clinicaltrials.gov. The listing was first posted on March 16th, 2021 and updated February 3rd, 2022."
Answered by AI
Are there any current vacancies in this clinical trial for new patients?
"The answer is affirmative. The clinical trial in question, which was originally posted on March 16th 2021 and updated February 3rd of this year, is still looking for 96 individuals across 2 sites."
Answered by AI
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